5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial.
Publication/Presentation Date
6-20-2015
Abstract
BACKGROUND: The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that mortality at 1 year, 2 years, and 3 years is much the same with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) for high-risk patients with aortic stenosis. We report here the 5-year outcomes.
METHODS: We did this randomised controlled trial at 25 hospitals, in Canada (two), Germany (one), and the USA (23). We used a computer-generated randomisation sequence to randomly assign high-risk patients with severe aortic stenosis to either SAVR or TAVR with a balloon-expandable bovine pericardial tissue valve by either a transfemoral or transapical approach. Patients and their treating physicians were not masked to treatment allocation. The primary outcome of the trial was all-cause mortality in the intention-to-treat population at 1 year, we present here predefined outcomes at 5 years. The study is registered with ClinicalTrials.gov, number NCT00530894.
FINDINGS: We screened 3105 patients, of whom 699 were enrolled (348 assigned to TAVR, 351 assigned to SAVR). Overall mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 11·7%. At 5 years, risk of death was 67·8% in the TAVR group compared with 62·4% in the SAVR group (hazard ratio 1·04, 95% CI 0·86-1·24; p=0·76). We recorded no structural valve deterioration requiring surgical valve replacement in either group. Moderate or severe aortic regurgitation occurred in 40 (14%) of 280 patients in the TAVR group and two (1%) of 228 in the SAVR group (p
INTERPRETATION: Our findings show that TAVR as an alternative to surgery for patients with high surgical risk results in similar clinical outcomes.
FUNDING: Edwards Lifesciences.
Volume
385
Issue
9986
First Page
2477
Last Page
2484
ISSN
1474-547X
Published In/Presented At
Mack, M. J., Leon, M. B., Smith, C. R., Miller, D. C., Moses, J. W., Tuzcu, E. M., Webb, J. G., Douglas, P. S., Anderson, W. N., Blackstone, E. H., Kodali, S. K., Makkar, R. R., Fontana, G. P., Kapadia, S., Bavaria, J., Hahn, R. T., Thourani, V. H., Babaliaros, V., Pichard, A., Herrmann, H. C., … PARTNER 1 trial investigators (2015). 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet (London, England), 385(9986), 2477–2484. https://doi.org/10.1016/S0140-6736(15)60308-7
Disciplines
Medicine and Health Sciences
PubMedID
25788234
Department(s)
Department of Surgery
Document Type
Article